Various diagnostic testing methods and kits have been used in clinical environments, such as, for example, immunochromatographic assays, multi-immunoassay diagnostic systems that test for the presence of antigens and/or antibodies, assay sample analyzing devices, and rapid immunoassay test strips. Other rapid assay test devices and methodologies may be known to a greater or lesser extent in the art, and these may be categorized into one of a number of formats, depending on whether the sample being tested flows through the device, and possibly also depending on the manner and/or direction of any such flow. For example, test devices may have a dipstick, a flow-through, and/or a lateral flow format.
There is, however, a continuing need for a test device that may provide quicker and more accurate test results, that may not require the purchase of additional specialized equipment nor the supplemental training of already highly qualified testing personnel, and/or that may enable a single analyte sample to be tested on a substantially contemporaneous basis for the presence of any of a plurality of causative agents. There is likewise a need for an immunodiagnostic test system, kit and/or device (which may, hereinafter, simply be referred to as an “immunodiagnostic test system”) that is effective and simple to use, and may be quickly administered.
There is also a pressing need—one that has not been adequately addressed by previous devices—for a test system that might be readily used and/or disposed of at the “point of care” and/or “in the field” (that is, outside of traditional clinical environments whether, for example, as part of a temporary outreach program, emergency response effort, in a field hospital, and/or in an actual field tending to a plant crop or a herd of afflicted livestock).
Additionally, there is a need for a test system that may be manufactured and/or assembled in the field and/or in a manufacturing facility that is specifically designed for that purpose. There is also a need for such a system that might also involve lower production and packaging costs.
A further need exists for a test system that may be selectively adaptable to provide either qualitative and/or quantitative results, depending on user preferences and/or the nature of the test to be conducted.
Previously, the disposal of “point of care” immunodiagnostic systems may have posed a significant difficulty or problem for those workers given this duty. In the past, such a device (that had been potentially contaminated device following its use) would typically have been sent to a landfill for disposal, thus giving rise to a whole host of environmental costs and concerns, including the potential that, over time, contaminants from the device might seep into the landfill and its surrounding regions. Landfill disposal of some currently marketed immunodiagnostic test systems has heretofore been substantially necessitated by the fact that such systems have typically been primarily composed of materials (such as plastic) that cannot be safely burned or incinerated without generating harmful and/or toxic fumes. The disposal of test systems in landfills has also typically involved additional transportation and disposal costs and efforts. Partially because of this last fact, field workers have been required to carry portable waste containers suited to securely transporting and disposing of such potentially contaminated test systems. Such waste procedures may have involved sterile glassware, plastic ware, laboratory ware, and the like, as well as correspondingly stringent sterilizing and handling regimes. Accordingly, there is a continuing and acutely felt need for a test system that might be readily disposed of in a simple yet ecologically responsible manner, such as, for example, by incineration over an open fire.
There is also a need for a test system that may be selectively adaptable to detect for viral, fungal, bacterial, and/or vector induced infections, any or all of these tests possibly being performed using a single sample.
In addition to all of the foregoing, there is a need for a test system that provides visually discernable test results and/or results within a relatively short period of time, such as, for example, within sixty to ninety seconds.
Accordingly, it is an object of the invention to obviate, mitigate, and/or address one or more of the above mentioned needs, shortcomings and/or disadvantages associated with the prior art.
Additionally, there is a need for a test system that may be used with solid and/or liquid test samples, that enables a substantially clear result which is unobstructed and/or unclouded by non-analyte particulate matter that may be present in the test samples.